Trial · NCT02160145
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
NCT02160145, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2018-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease. Trials, record NCT02160145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02160145
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
- NCT number
- NCT02160145
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,370 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease
- Interventions
- Tolvaptan (OPC-41061), Placebo
- First posted
- 2014-06-10
- Last updated
- 2018-08-08
- Results first posted
- 2018-08-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up. | Pretreatment baseline to post-treatment follow-up (up to 61 weeks). | The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration. The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods. |
| Secondary | Mean Annualized Slope of eGFR Change | Pretreatment baseline to post-treatment follow-up (up to 61 weeks). | To compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period, the annualized rate of eGFR change was derived from each individual subject's eGFR slope using the CKD-EPI formula. The annualized eGFR change slope was derived from all eGFR observations from placebo-run-in, tolvaptan run-in, double-blind treatment and post-treatment follow-up periods using the linear mixed model of analysis. The mean annualized slope of eGFR change is presented. |
| Other | Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up | Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up. | The mean change from baseline in urine osmolality for the double-blind treatment period collection timepoints and post-treatment follow-up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing. |
| Other | Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up | Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up. | The mean change from baseline in urine specific gravity for the double-blind treatment period collection timepoints and post-treatment follow up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up. | Pretreatment baseline to post-treatment follow-up (up to 61 weeks). | The primary endpoint efficacy population consisted of all subjects who were in the randomized sample, took at least 1 dose of investigational medicinal product (IMP) after randomization, and had a baseline and at least 1 valid post-treatment evaluation in eGFR (i.e at least 1 week off-treatment). | mL/min/1.73 m^2/year | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Annualized Slope of eGFR Change | Pretreatment baseline to post-treatment follow-up (up to 61 weeks). | The key secondary endpoint efficacy population consisted of all randomized subjects who took at least 1 dose of IMP after randomization, and have a baseline (average of up to 3 eGFR values observed during screening and placebo run-in periods) and at least 1 post-randomization evaluation in eGFR during the double-blind treatment period. | mL/min/1.73m^2/year | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up | Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up. | The primary safety population consisted of all subjects who were randomized and took at least 1 dose of IMP after randomization. Only subjects with data available for analysis at the timepoints of testing are presented. | milliosmole per kilogram (mOSm/kg) | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up | Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up. | The primary safety population consisted of all subjects who were randomized and took at least 1 dose of IMP after randomization. Only subjects with data available for analysis at the timepoints of testing are presented. | unitless | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up. | Tolvaptan | -2.339 | Standard Error 0.240 | mL/min/1.73 m^2/year | |
| The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up. | Placebo | -3.610 | Standard Error 0.240 | mL/min/1.73 m^2/year | |
| Mean Annualized Slope of eGFR Change | Tolvaptan | -3.160 | Standard Error 0.140 | mL/min/1.73m^2/year | |
| Mean Annualized Slope of eGFR Change | Placebo | -4.170 | Standard Error 0.142 | mL/min/1.73m^2/year | |
| Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up | Tolvaptan | Month 3 | 10.2 | Standard Deviation 80.3 | milliosmole per kilogram (mOSm/kg) |
| Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up | Placebo | Month 3 | 177.7 | Standard Deviation 124.5 | milliosmole per kilogram (mOSm/kg) |
| Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up | Tolvaptan | Month 6 | 22.9 | Standard Deviation 84.3 | milliosmole per kilogram (mOSm/kg) |
| Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up | Placebo | Month 6 | 179.1 | Standard Deviation 126.2 | milliosmole per kilogram (mOSm/kg) |
| Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up | Tolvaptan | Month 9 | 30.4 | Standard Deviation 92.1 | milliosmole per kilogram (mOSm/kg) |
| Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up | Placebo | Month 9 | 179.9 | Standard Deviation 125.1 | milliosmole per kilogram (mOSm/kg) |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Prerandomization Single-blind Period | STARTED | All Subjects Prerandomization | 1,519 | |
| Prerandomization Single-blind Period | STARTED | Tolvaptan | 0 | |
| Prerandomization Single-blind Period | STARTED | Placebo | 0 | |
| Prerandomization Single-blind Period | Treated in Placebo Run-in | All Subjects Prerandomization | 1,514 | |
| Prerandomization Single-blind Period | Treated in Placebo Run-in | Tolvaptan | 0 | |
| Prerandomization Single-blind Period | Treated in Placebo Run-in | Placebo | 0 | |
| Prerandomization Single-blind Period | Treated in Tolvaptan Titration/Run-in | All Subjects Prerandomization | 1,491 | |
| Prerandomization Single-blind Period | Treated in Tolvaptan Titration/Run-in | Tolvaptan | 0 | |
| Prerandomization Single-blind Period | Treated in Tolvaptan Titration/Run-in | Placebo | 0 | |
| Prerandomization Single-blind Period | Randomized | All Subjects Prerandomization | 1,370 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events441
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Tolvaptan (Single-blind Treatment Period) | 132 | 1,491 | 134 |
| other | Dry mouth | Gastrointestinal disorders | Tolvaptan (Double-blind Treatment Period) | 0 | 681 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Placebo (Double-blind Treatment Period) | 0 | 685 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Tolvaptan (Single-blind Treatment Period) | 0 | 1,491 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Tolvaptan (Double-blind Treatment Period) | 47 | 681 | 54 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Double-blind Treatment Period) | 23 | 685 | 25 |
| other | Thirst | General disorders | Tolvaptan (Single-blind Treatment Period) | 430 | 1,491 | 453 |
| other | Thirst | General disorders | Tolvaptan (Double-blind Treatment Period) | 0 | 681 | 0 |
| other | Thirst | General disorders | Placebo (Double-blind Treatment Period) | 0 | 685 | 0 |
| other | Fatigue | General disorders | Tolvaptan (Single-blind Treatment Period) | 0 | 1,491 | 0 |
1 to 10 of 441Source ClinicalTrials.gov
See all 441 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan (Single-blind Treatment Period) | 1 | 1,491 |
| Total, all-cause mortality | Tolvaptan (Double-blind Treatment Period) | 0 | 681 |
| Total, all-cause mortality | Placebo (Double-blind Treatment Period) | 1 | 685 |
| Total, other adverse events | Tolvaptan (Single-blind Treatment Period) | 1,051 | 1,491 |
| Total, other adverse events | Tolvaptan (Double-blind Treatment Period) | 581 | 681 |
| Total, other adverse events | Placebo (Double-blind Treatment Period) | 564 | 685 |
| Total, serious adverse events | Tolvaptan (Single-blind Treatment Period) | 43 | 1,491 |
| Total, serious adverse events | Tolvaptan (Double-blind Treatment Period) | 85 | 681 |
| Total, serious adverse events | Placebo (Double-blind Treatment Period) | 60 | 685 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02160145
GET https://conductscience.org/api/trials/v1/NCT02160145/results?page=2